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Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985894
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 29, 2009
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE September 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
  • Eczema Area and Severity Index (EASI) [ Time Frame: Every 8 weeks ]
  • Patient-oriented Eczema Measure (POEM) [ Time Frame: Every 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis
Official Title  ICMJE Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits
Brief Summary

The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.

The investigators' hypotheses include the following:

  1. Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity.
  2. Compared to in-person visits, the online care model will result in similar improvements in quality of life.
  3. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Other: Online Teledermatology Care
    Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.
    Other Name: Health care service modality
  • Other: Conventional in Office Care
    Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
    Other Name: Health care service modality
Study Arms  ICMJE
  • Experimental: Teledermatology
    Online Telemedicine Group
    Intervention: Other: Online Teledermatology Care
  • Active Comparator: Usual Care
    Conventional in-office care
    Intervention: Other: Conventional in Office Care
Publications * Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
183
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2009)
140
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 4 years or older at time of consent, may be male or female.
  • Meet the Hanifin diagnostic criteria for atopic dermatitis.
  • Capable of giving informed consent (for patients less than 18 years of age, assent will be obtained from the minor and informed consent will be obtained from a legal guardian).
  • Able to image their skin or have someone do it for them.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Have access to a computer with internet connection, a digital camera, and an e-mail address.

Exclusion Criteria:

  • Non English speaking patients.
  • Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
  • Patients requiring close laboratory monitoring.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985894
Other Study ID Numbers  ICMJE 200917162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: April W Armstrong, MD UC Davis Department of Dermatology
PRS Account University of California, Davis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP